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Trial Title:
Apatinib Mesylate Versus Standard Second-line TKI in the Treatment of Advanced GIST
NCT ID:
NCT05751733
Condition:
Gastrointestinal Stromal Tumors
Conditions: Official terms:
Gastrointestinal Stromal Tumors
Sunitinib
Apatinib
Imatinib Mesylate
Dasatinib
Conditions: Keywords:
Gastrointestinal Stromal Tumors
Apatinib mesylate
tyrosine kinase inhibitors
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Apatinib Mesylate
Description:
Apatinib Mesylate (Etan) is a new type of small molecule anti-angiogenic agent, which is
a small molecule TKI against VEGFR2 independently developed in China and has the effect
of anti-C-Kit and PDGFR.
Arm group label:
Experimental group
Intervention type:
Drug
Intervention name:
Sunitinib, Imatinib dosage, Dasatinib, Reveratinib
Description:
Second-line TKI drugs
Arm group label:
Control group
Summary:
The goal of this Mesylate apatinib versus standard second-line TKI in the treatment of
advanced gastrointestinal stromal tumors: a randomized, open, controlled, single-center
clinical study is to explore the efficacy and safety of Apatinib compared with
second-line treatment in advanced GIST patients with first-line TKI failure. The main
questions it aims to answer are:
- To explore the efficacy and safety of Apatinib compared with standard second-line
treatment for GIST with advanced first-line TKI failure.
- To explore the expression level and MVD value of VEGFR2 in GIST, and to explore the
relationship between the expression level and the location, size, mitotic image and
recurrence risk grading of GIST.
Patients with advanced GIST were randomly included in the trial group and the control
group at a ratio of 1:1.
Detailed description:
The objectives of this study were as follows:
1. To explore the efficacy and safety of Apatinib compared with standard second-line
treatment of advanced GIST with first-line TKI failure, and to provide high-level
clinical evidence for the treatment of late-stage plasmatoma;
2. Explore the expression level and MVD value of VEGFR2 in GIST, and explore the
relationship between the expression level and the location, size, mitotic image and
recurrence risk grading of GIST.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients were enrolled voluntarily and signed a written informed consent with good
compliance and follow-up;
2. Age ≥18 years (calculated on the date of signing the informed consent) for both men
and women;
3. Previous first-line TKI (Imatinib/Avatinib) therapy and eventual treatment failure
(disease progression or toxicity intolerance during treatment);
4. Subjects who provide pre-C-Kit /PDGFRA test reporting can provide 10ml blood sample
and fresh or archived tumor tissue for genetic testing.
5. ECOG score: 0 ~ 1;
6. Predicted survival ≥12 weeks.
Exclusion Criteria:
1. Previous molecular targeted therapy other than imatinib/Avatinib for the treatment
of gastrointestinal stromal tumor;
2. Toxicity of previous imatinib/Avatinib treatment or other treatments has not
recovered or reached NCICTCAE5.0≤ level 1;
3. Patients with clinical symptoms of ascites or pleural effusion who need puncture
drainage or who have received thoracic and ascites drainage within 1 month before
signing informed consent, except those who only show a small amount of ascites or
pleural effusion without clinical symptoms;
4. A second primary malignancy within the last 5 years, except for basal cell
carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix
that has been adequately treated;
5. Gastrointestinal stromal tumor with central nervous system metastasis;
6. Inability to swallow, chronic diarrhea and intestinal obstruction, with multiple
factors affecting drug administration and absorption.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Xiangya Hospital, Central South University
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Recruiting
Contact:
Last name:
Gang Cheng, Ph.D
Phone:
15111489917
Email:
gangcheng0307@163.com
Investigator:
Last name:
Heli Liu, Ph.D
Email:
Principal Investigator
Start date:
February 1, 2023
Completion date:
January 1, 2027
Lead sponsor:
Agency:
Xiangya Hospital of Central South University
Agency class:
Other
Collaborator:
Agency:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
Xiangya Hospital of Central South University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05751733
